Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
RABEPRAZOLE SODIUM
Specifar S.A.
10 Milligram
Tablets Gastro-Resistant
2012-03-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rabeprazole sodium Specifar 10mg gastro-resistant tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 10 mg rabeprazole sodium, equivalent to 9.42 mg rabeprazole. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet Pink, round, biconvex gastro-resistant tablets with a diameter of 6 mm approximately. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rabeprazole sodium Specifar tablets are indicated for the treatment of: Active duodenal ulcer Active benign gastric ulcer Symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD). Gastro-Oesophageal Reflux Disease Long-term Management (GORD Maintenance) Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD) Zollinger-Ellison Syndrome In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease (See section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS/ELDERLY: _ACTIVE DUODENAL ULCER AND ACTIVE BENIGN GASTRIC ULCER: _The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing. _EROSIVE OR ULCERATIVE GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD): _The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks. _GASTRO-OESOPHAGEAL REFL Read the complete document